Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.

Study Phase:

2

Recruitment Status:

Trial Completed

Study Drug(s):

Methotrexate

Number of Participants Being Recruited:

20

Single / Multi-Center:

Single Center

STUDY BACKGROUND INFORMATION:

This study examined the role of a drug in reducing inflammation commonly seen in CF lung disease. Increased production of mucus in patients with CF contributes to the increase of bacteria that lead to lung infection and inflammation. Researchers want to determine if a drug called methotrexate can decrease inflammation in cystic fibrosis lung disease. Methotrexate is an approved drug that has been used successfully to reduce steroid dependency in severe asthma.

ELIGIBILITY

Age:

>= 14 Years

FEV1:

>= 40 Percent Predicted

P. aeruginosa status:

Not applicable

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

Eight patients were enrolled in this study and received once weekly dosing with low dose methotrexate for 12 weeks to evaluate its potential anti-inflammatory effect. Six subjects completed the study, and two withdrew due to adverse events potentially related to study drug. IL-8 and free elastase and other cytokines (in induced sputum) increased during treatment.

Secondary Efficacy:

Overall measures of lung functions declined during the study as did weight.

Safety:

Adverse effects were primarily gastrointestinal.

The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2007). These data may be preliminary and have not been peer-reviewed.